Trial record 10 of 40 for:    Temporal arteritis

Carotid Artery Neovascularization in Takayasu's and Giant Cell Arteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Soo Hyun (Esther) Kim, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01795456
First received: February 18, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound to serve as an indicator of disease activity in patients with Takayasu's arteritis or Giant Cell arteritis and to determine if patients with active arteritis have a thickening of their blood vessel walls compared to healthy people of the same age and gender.


Condition
Takayasu's Arteritis
Giant Cell Arteritis
Arteritis
Vasculitis
Aortitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Contrast Enhanced Ultrasound for Assessment of Carotid Artery Neovascularization as a Marker of Disease Activity in Takayasu's Arteritis and Giant Cell Arteritis

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Correlation between carotid IMT and neovascularization and disease activity [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Takayasu's arteritis and Giant Cell arteritis are chronic, relapsing diseases of the large arteries which can lead to significant narrowing of the arteries through episodes of inflammation within the artery walls. The changes in the vessel walls will be determined by an ultrasound test looking at and measuring: carotid vessel wall changes called carotid Intimal-Media Thickness (cIMT) and the presence of new blood vessels (neovascularization) using a contrast agent. Ultrasound findings will be correlated with markers of inflammation in the blood, findings from other radiology studies (such as MRI) already ordered as part of routine clinical care, and physical exam findings and symptoms of consistent with disease activity. 15 arteritis patients and 5 healthy controls will be recruited.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with Takayasu's arteritis or giant cell arteritis will be screened from the clinics of the Vasculitis Clinic and the Vascular Medicine Clinic at the Cleveland Clinic.

Criteria

Inclusion Criteria:

  • Male and female patients >18 years
  • Diagnosis of Takayasu's arteritis or giant cell arteritis
  • Suspicion of common carotid involvement on the basis of physical examination (cervical bruit), carotidynia, documented CCA involvement on an imaging study (MRA, CTA, or ultrasound), or documented upper extremity large vessel involvement on an imaging study (MRA or CTA or ultrasound).
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior stroke, carotid surgery or angioplasty
  • Pregnant (or trying to become pregnant)
  • Nursing
  • Known or suspected cardiac shunt
  • Documented hypersensitivity to the contrast agent
  • Severe pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, or respiratory failure)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795456

Contacts
Contact: Neil Poria, BS,MA 216-444-0334 porian@ccf.org
Contact: Soo Hyun Kim, MD, MPH 216-444-1680 kims@ccf.org

Locations
United States, Ohio
Cleveland Clinic Main Campus, Section of Vascular Medicine Recruiting
Cleveland, Ohio, United States, 44011
Contact: Neil Poria, BS, MA    216-444-0334      
Sponsors and Collaborators
The Cleveland Clinic
GE Healthcare
  More Information

No publications provided

Responsible Party: Soo Hyun (Esther) Kim, Staff physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01795456     History of Changes
Other Study ID Numbers: 10-595
Study First Received: February 18, 2013
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Takayasu's arteritis
Giant Cell arteritis
Arteritis
Vasculitis
Aortitis
Disease Activity
Carotidynia
Neovascularization
Carotid Intima Media Thickness

Additional relevant MeSH terms:
Arteritis
Takayasu Arteritis
Giant Cell Arteritis
Aortitis
Neovascularization, Pathologic
Aortic Arch Syndromes
Polymyalgia Rheumatica
Vasculitis
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Metaplasia
Pathologic Processes
Skin Diseases, Vascular
Skin Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 20, 2014